European Medicines Agency EMA has received an application for a Conditional Marketing Authorization (CMA) for a vaccine COVID-19 mRNA from Moderna Biotech Spain, SL As announced, the evaluation of the vaccine known as the Moderna vaccine Covid-19 (also referred to as mRNA1273) will proceed as soon as possible. An opinion on the marketing authorization could be issued within weeks, depending on whether the data submitted is strong and complete enough to show the quality, safety and efficacy of the vaccine, according to Coreper.
As he explains, "such a short period of time is only possible because the EMA has already examined some data on the vaccine during a rolling review". During this phase, the EMA evaluated data from laboratory studies and also began evaluating data on immunogenicity (how well the vaccine elicits an antiviral response) and safety from an early study.
The EMA will now evaluate the data submitted as part of the formal conditional marketing authorization application.
The Agency and its scientific committees will continue to work on the evaluation during the Christmas period.
If the data submitted are strong enough to arrive at the quality, safety and efficacy of the vaccine, the EMA Scientific Committee for Human Medicines (CHMP) will complete its evaluation during an extraordinary meeting scheduled for January 12 at the latest.
These schedules are based on the type of data that has been evaluated so far in the rolling review and may change as the evaluation progresses. The EMA will communicate the outcome of its assessment.
Source: KYPE